Success and Survival Rate of Tranmucosal Versus Bone Level Implants: Randomized Clinical Trial

NCT06252324 | Active Not Recruiting

• 1 other identifier: 596-2022-SPER-AUSLBO
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess changes in peri-implant tissues and the effectiveness of a tissue-level surgical technique. This technique will be compared with a bone-level surgical technique. This is a post-marketing clinical investigation conducted in the Endodontics Department of the Dental Clinic at the University of Bologna. Patient recruitment and study conduction will follow the principles of the Declaration of Helsinki and adhere to major international guidelines (CONSORT). Implants will be placed using either a bone-level or tissue-level surgical technique, corresponding to implants positioned at the level of the gingival mucosa or submerged implants, respectively. Randomization (1:1 ratio) will be conducted before surgery to create two treatment groups. The experimental group (Tissue Level) (n=40) consists of implants that will be placed with the exposed neck (Tissue-level surgical technique). The control group (n=40) comprises implants placed at the bone level (Bone-level surgical technique). The surgeon will be aware of patient assignment during the implant insertion procedures. The surgical procedure to uncover the implant neck (control group) will be performed 3 months after implant placement. The experimental group (Tissue Level technique) will not require a surgical intervention. he following parameters will be assessed at 1, 6, 12, and 36 months after implant placement: Peri-implant parameters: Plaque score, Bleeding on Probing (BoP), and Papilla Index Radiographic parameters: Marginal Bone Level (MBL) Patient-Reported Outcome Measure (PROM): Post-operative pain (VAS) in the experimental group (non-submerged surgical technique) and the control group (submerged surgical technique).

Conditions

Bone Loss

Outcome Measures

Primary Outcomes (2)

• Marginal bone level (MBL) around implants

  analysis of bone level variations at different time frames

  immediately after implant insertion, 1 month, 3 months, 6 months, 12 months, 24 months and 36 months.

• implant survival rate

  number of implants still functional at the end of the follow-up

  12 months, 24 months, 36 months from insertion

Secondary Outcomes (1)

• post-operative pain

  immediately after insertion, 3months after insertion (crown and abutment applications)

Study Arms (2)

submerged implant placement with healing abtument

EXPERIMENTAL

the implant was placed flush to the bone crest after anaesthesia and with no flap elevation. A healing screw was positioned to have a transmucosal healing. the healing was removed after 3 months and cement restoration technique was performed in all cases.

Other: Prime taper implant + healing screw

Tissue level implant placement cover screw

OTHER

the implant was placed above the bone crest after anaesthesia and with no flap elevation. A cover screw was positioned to have a tissue level healing. the screw was removed after 3 months and cement restoration technique was performed in all cases.

Other: Prime taper implant + cover screw

Interventions

Prime taper implant + cover screw OTHER

tissue level implant placement with the addition of a cover screw

Also known as: nonsubmerged healing

Tissue level implant placement cover screw

Prime taper implant + healing screw OTHER

bone level implant placement with the addition of a healing screw

Also known as: submerged healing

submerged implant placement with healing abtument

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18-75 years;
• Healthy or with mild functional limitations according to ASA classification 1-2 (16);
• Consumption of fewer than 10 cigarettes per day;
• Need for implant rehabilitation in a single-tooth edentulous area;
• Presence of adequate volumes of bone tissue (3.5mm thickness and 9mm height) to allow proper implant placement and optimal primary stability.

You may not qualify if:

• Age under 18 years;
• Medical and/or general contraindications to surgical procedures (ASA score ≥3) (16);
• Poor oral hygiene and lack of motivation and/or active clinical periodontal disease expressed by probing pocket depth \>4 mm and bleeding on probing;
• Smoking more than 10 cigarettes per day;
• Systemic or local diseases that could compromise post-operative healing and osseointegration;
• Alcohol and/or drug abuse;
• Pregnancy or breastfeeding;
• Malocclusion and other occlusal disorders;
• Bisphosphonate therapy.

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

Endodontic clinical section, DIBINEM, UNiversity of Bologna

Bologna, 40125, Italy

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Maria Giovanna Gandolfi

  Dibinem, University of Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fausto Zamparini

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: January 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

IT (1)